SCOPE OF WORK

A Bioequivalence study for an oncology product. 

THE CHALLENGE

To enroll 75 female cancer patients into an Indian Bioequivalence study where extensive blood sampling was required.

THE CLINTEC APPROACH

Patients were enrolled at multiple sites to expedite recruitment.  In addition, referral centers were implemented to boost recruitment at each participating site. ClinTec completed recruitment within 4 months at 6 sites. The identificationof an experienced logistics vendor and the challenges of coordinating multiple sites was addressed to overcome the challenge of sample handling, processing and shipment.

THE OUTCOME

ClinTec successfully met the recruitment target within the aggressive timelines and coordinated the logistics of all samples for central analysis.